NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder 
Cellchem Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Nighttime Symptom Relief
Extra Strength
For Symptoms Of Cold And Cough

Drug Facts

Active Ingredients (in each packet)                                                   Purpose

Acetaminophen 650 mg..................................................Pain reliever/Fever reducer

Diphenhydramine Hydrochloride 25 mg.............Antihistamine/ Cough Suppressant

Phenylephrine Hydrochloride 10 mg.............................................Nasal decongestant

Uses

Temporarily relieves these symptoms due to a cold:
o
minor aches and pains  
o
headache
o
minor sore throat pain
o
nasal and sinus congestion
o
cough due to minor throat and bronchial irritation
o
runny nose
o
sneezing
o
itchy, watery eyes due to hay fever
o
itchy nose or throat
Temporarily reduce fever

Relieves:

Nasal congestion
Sore throat pain
Cough
Headache
body aches
Fever
Runny nose
Sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 packets in 24 hours, which is the maximum daily amount 
with other drugs containing acetaminophen 
3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

skin reddening 
blisters
rash. If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

in children under 12 years
if you are allergic to acetaminophen, phenylephrine or any other ingredient in this product
with any other drug containing acetaminophen, phenylephrine. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on the skin
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema, asthma, or chronic bronchitis 
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a sodium restricted diet.

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
the blood thinning drug warfarin 

When using this product

do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur 
alcohol, sedatives and tranquilizers may increase drowsiness 
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If pregnant or breast-feeding, ask a health care professional before use.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE.
DO NOT DISCARD.
DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

Directions

do not use more than directed
take every 4 hours, while symptoms persist.

Do not take more than 6 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years and over

one packet

children under 12 years

do not use

dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other Information

each packet contains: potassium 10 mg, sodium 47 mg.
phenylketonurics: contains phenylalanine 13 mg per packet.
store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.

Inactive ingredients

Acesulfame potassium, anhydrous citric acid, aspartame, caramel, D&C Yellow #10, maltodextrin, natural flavors, sodium citrate, starch and sugar.

Questions, Comments or Adverse Reactions?

You may report serious side effects to: +1 844-481-8884
Serious side effects can also be reported to: drugsafety@cellchempharma.ca

Distributed by:
CellChem Pharmaceuticals Inc.
Unit 1, 30 Concourse Gate
Nepean, Ontario K2E 7V7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonlabel
pouch
NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73147-3109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CARAMEL (UNII: T9D99G2B1R)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorHONEY (honey lemon infused with Chamomile & white tea flavors) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73147-3109-66 in 1 CARTON; Type 0: Not a Combination Product07/01/201912/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201912/31/2023
Labeler - Cellchem Pharmaceuticals Inc (111518618)
Registrant - Cellchem Pharmaceuticals Inc (111518618)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Confab Inc241754217MANUFACTURE(73147-3109)

Revised: 11/2022
 
Cellchem Pharmaceuticals Inc